Jobs, fresher vacancy - Specialist, Regulatory Affairs - Hungary- Home or Office-Based • UK

Company: Lifelancer

UK

Were a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the worlds most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.We are Worldwide Clinical Trials, and we are a global team of almost 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs in the best possible way.Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.What You Will DoYou will be a subject matter expert and local point of contact for activities supporting Regulatory submissions, site activation and maintenance for awarded projects.You will be responsible for planning, initiating and tracking documents required for regulatory submissions, essential documents collection, review and provision of country/site/EC requirements to support achievement of site activation goals and communicating status, risks and actions related to any start-up activities and maintenance when applicable. What You Will Bring To The RoleStrong organizational and management skills. Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.Self-motivated learning about current regulatory processes and intelligenceProactive by identifying potential issues in the process and anticipating solutionsThorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnelEasily adjusts to a changing environment; ability to prioritize adapt between detailed and strategic activities while maintaining delivery timelines and qualityTeam-oriented work style; seeks and gives guidance to others Your ExperienceDegree with a major concentration in medical, biological, physical, health, pharmacy or other related scienceMinimum two year of experience in clinical research, in site activation and/or regulatory-related function within a CROCandidates must have experience of the regulatory process in Hungary to be considered for this role.Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulationsMultilingualism preferred; fluent in local language; working knowledge of English Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.Please use the below Lifelancer link for job application and quicker response.https://lifelancer.com/jobs/view/d95079d408d50bf0a22075a9606f3ed0